OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease
The principal aim of the study is to determine the effects n3-PUFA on top of standard therapy on surrogate markers of disease severity and/or prognosis in patients with PAD.
Treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion.
Primary outcome parameter is endothelial function assessed by flow-mediated vasodilation using brachial artery ultrasound.
Secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse wave velocity, whole blood viscosity, platelet activation and plasma markers of inflammation.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||OMEGA-3-POLYUNSATURATED FATTY-ACIDS (n3-PUFA) IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE: EFFECTS ON ENDOTHELIAL FUNCTION - A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL|
- change from baseline endothelial function to 3 months [ Time Frame: baseline, 3 months ]measured by flow mediated vasodilation
- change from baseline endothelial function to six months [ Time Frame: baseline, 6 months (3 months after treatment cessation) ]
- change of walking distance (maximum/pain-free)from baseline to three months and six months [ Time Frame: baseline, 3, 6 months ]
- change of inflammatory markers from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ]
- change of pulse wave velocity from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ]
- bleeding events [ Time Frame: 1, 3, 6 months ]
- liver enzymes changes [ Time Frame: baseline, 1,3,6 months ]
- change of platelet activation from baseline to one, three and six months [ Time Frame: baseline, 1, 3, 6 months ]
|Study Start Date:||January 2011|
|Study Completion Date:||March 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Omacor||
4 capsules OMACOR 1g per day
|Placebo Comparator: Placebo||
4 capsules placebo per day
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367145
|Medical University of Vienna, Department of Internal Medicine II, Division of Angiology|
|Vienna, Austria, 1090|
|Principal Investigator:||Sabine Steiner, Dr.||Medical University of Vienna|